510(k) Report

Devices descending from DEN150011

8 later devices reach Sonablate 450 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153023Ablatherm Integrated ImagingEdap Technomed, Inc.201571
+2K191200TULSA-PRO SystemProfound Medical, Inc.20193—
+2K172721Focal OneEdap Technomed, Inc.20181—
+2K172285Ablatherm FusionEdap Technomed, Inc.20170—
+3K251910Focal One®Edap Technomed, Inc.20250—
+3K230692TULSA-PRO SystemProfound Medical, Inc.20230—
+3K211858TULSA-PRO SystemProfound Medical, Inc.20220—
+3K202286Tulsa-Pro SystemProfound Medical, Inc.20200—